An observational study in Urothelial Bladder Carcinoma, Bladder Carcinoma and Non-Muscle-Invasive Bladder Cancer (NMIBC), sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Assiut University · Observational
Bladder cancer is a significant global and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment. This observational study aims to evaluate two specific microscopic features of urothelial bladder carcinoma to see if they can reliably predict patient outcomes: the depth of early tumor invasion (T1 substaging) and the presence of small clusters of cancer cells at the tumor's edge (Tumor Budding).
Researchers will retrospectively analyze tissue samples (paraffin blocks) from at least 100 patients who were diagnosed with urothelial bladder carcinoma and underwent transurethral resection (TUR) at the South Egypt Cancer Institute between 2018 and 2024.
The tissue samples will be analyzed in two main ways:
By comparing these detailed microscopic measurements with the patients' historical medical records, the study hopes to determine if T1 substaging and Tumor Budding are strong predictors of disease recurrence, disease progression, and overall patient survival.
Bladder carcinoma remains a major global oncological burden, exerting a substantial impact on patient morbidity and mortality. In Egypt, it constitutes a significant public health concern with distinctive epidemiological characteristics. While squamous cell carcinoma historically predominated, a substantial shift has occurred over recent decades, and urothelial carcinoma has emerged as the dominant subtype, accounting for approximately 75-80% of cases.
Pathological assessment traditionally focuses on histological grade and invasion depth. The precise assessment of invasion depth is critical, particularly in T1 non-muscle-invasive urothelial carcinoma, where the tumor invades the lamina propria. Multiple sub-classification systems exist for T1 tumors, including anatomical approaches relative to the muscularis mucosae and semiquantitative micrometric methods, yet no single method has been adopted universally. Furthermore, in muscle-invasive disease, the morphology of the invasive front provides crucial biological insights. Tumor budding, defined as single isolated cancer cells or small clusters of fewer than five cells at the invasive front, is recognized as a morphological hallmark of epithelial-mesenchymal transition (EMT) and reflects aggressive tumor potential.
This study evaluates archived hematoxylin and eosin (H\&E)-stained slides from patients who underwent transurethral resection (TUR) for urothelial carcinoma between 2018 and 2024. Histological subtypes will be confirmed according to the 2022 World Health Organization (WHO) classification, and tumor grade and stage will be determined using the American Joint Committee on Cancer (AJCC) 8th edition. Additional pathological parameters assessed will include tumor size, multifocality, coagulative tumor necrosis, lympho-vascular invasion (LVI), and perineural invasion (PNI).
The histopathological procedures are divided into two primary evaluations:
The study population consists of patients diagnosed with urothelial bladder carcinoma who underwent transurethral resection (TUR) at the South Egypt Cancer Institute (SECI), Assiut University, between the years 2018 and 2024. The study utilizes retrospectively collected, archived paraffin-embedded tissue blocks along with corresponding clinical, pathological, and survival data retrieved from medical records and electronic pathology reports.
Exclusion Criteria:
All confirmed pT1 cases will undergo rigorous histopathological substaging. An anatomical substaging (T1a/b/c) will be performed by identifying the level of invasion relative to the muscularis mucosae. Additionally, micrometric assessment will be carried out using a 0.1 mm threshold and the Rete Oncologica Lombarda (ROL) system.
These cases will be evaluated for Tumor Budding. The "Hotspot" method will be used to count buds in one high power field at the invasive front. Cases will be graded as Low Budding (BD1): 0-4 buds, Intermediate Budding (BD2): 5-9 buds, and High Budding (BD3): ≥ 10 buds.
Overall Survival (OS)
Overall survival is defined as the length of time from the date of the transurethral resection (TUR) to the date of death from any cause. This outcome will be correlated with the assessed histopathological parameters (T1 substaging and Tumor Budding scores) to evaluate their prognostic significance in urothelial bladder carcinoma.
Time frame: Up to 72 months (retrospectively assessed spanning the 2018 to 2024 study period).
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Assiut University